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Serving leading biopharmaceutical companies globally:

Covington
Cantor Fitzgerald
US Department of Justice
Citi
UBS
Moodys
Boehringer Ingelheim
Julphar
McKesson
Fish and Richardson

Generated: November 25, 2017

DrugPatentWatch Database Preview

Bupropion hydrobromide - Generic Drug Details

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What are the generic drug sources for bupropion hydrobromide and what is the scope of bupropion hydrobromide patent protection?

Bupropion hydrobromide
is the generic ingredient in one branded drug marketed by Valeant Pharms North and is included in one NDA. There are eight patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Bupropion hydrobromide has forty-nine patent family members in seventeen countries and three supplementary protection certificates in three countries.

There are thirty-seven drug master file entries for bupropion hydrobromide. Two suppliers are listed for this compound. There is one tentative approval for this compound.

Pharmacology for bupropion hydrobromide

Tentative approvals for BUPROPION HYDROBROMIDE

Applicant Application No. Strength Dosage Form
u► Subscribe174MGTABLET, EXTENDED RELEASE; ORAL
u► Subscribe522MGTABLET, EXTENDED RELEASE; ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Valeant Pharms North
APLENZIN
bupropion hydrobromide
TABLET, EXTENDED RELEASE;ORAL022108-002Apr 23, 2008RXYesNo► Subscribe► SubscribeY ► Subscribe
Valeant Pharms North
APLENZIN
bupropion hydrobromide
TABLET, EXTENDED RELEASE;ORAL022108-003Apr 23, 2008RXYesYes► Subscribe► SubscribeY ► Subscribe
Valeant Pharms North
APLENZIN
bupropion hydrobromide
TABLET, EXTENDED RELEASE;ORAL022108-002Apr 23, 2008RXYesNo► Subscribe► SubscribeY ► Subscribe
Valeant Pharms North
APLENZIN
bupropion hydrobromide
TABLET, EXTENDED RELEASE;ORAL022108-002Apr 23, 2008RXYesNo► Subscribe► SubscribeY ► Subscribe
Valeant Pharms North
APLENZIN
bupropion hydrobromide
TABLET, EXTENDED RELEASE;ORAL022108-002Apr 23, 2008RXYesNo► Subscribe► SubscribeY ► Subscribe
Valeant Pharms North
APLENZIN
bupropion hydrobromide
TABLET, EXTENDED RELEASE;ORAL022108-001Apr 23, 2008RXYesNo► Subscribe► Subscribe ► Subscribe
Valeant Pharms North
APLENZIN
bupropion hydrobromide
TABLET, EXTENDED RELEASE;ORAL022108-002Apr 23, 2008RXYesNo► Subscribe► SubscribeY ► Subscribe
Valeant Pharms North
APLENZIN
bupropion hydrobromide
TABLET, EXTENDED RELEASE;ORAL022108-001Apr 23, 2008RXYesNo► Subscribe► SubscribeY ► Subscribe
Valeant Pharms North
APLENZIN
bupropion hydrobromide
TABLET, EXTENDED RELEASE;ORAL022108-003Apr 23, 2008RXYesYes► Subscribe► Subscribe ► Subscribe
Valeant Pharms North
APLENZIN
bupropion hydrobromide
TABLET, EXTENDED RELEASE;ORAL022108-003Apr 23, 2008RXYesYes► Subscribe► SubscribeY ► Subscribe
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Non-Orange Book Patents for Generic Ingredient: bupropion hydrobromide

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,553,992Modified release formulations of a bupropion salt► Subscribe
7,579,380Modified release formulations of a bupropion salt► Subscribe
7,645,901Modified release formulations of a bupropion salt► Subscribe
8,932,628Modified release formulations of a bupropion salt► Subscribe
8,354,453Bupropion hydrobromide and therapeutic applications► Subscribe
9,504,640Modified release formulations of a bupropion salt► Subscribe
7,884,136Modified-release formulations of a bupropion salt► Subscribe
7,569,611Modified release formulations of a bupropion salt► Subscribe
7,563,823Modified release formulations of a bupropion salt► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: bupropion hydrobromide

Country Document Number Estimated Expiration
Japan2008546841► Subscribe
China101784266► Subscribe
South Korea20100077182► Subscribe
China101534808► Subscribe
China101903016► Subscribe
Russian Federation2408368► Subscribe
Colombia6251360► Subscribe
Singapore183695► Subscribe
Australia2006261788► Subscribe
Canada2700733► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: BUPROPION HYDROBROMIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB00/019United Kingdom► SubscribePRODUCT NAME: BUPROPION HYDROCHLORIDE; REGISTERED: NL RVG 24160 19991201; UK PL 10949/0340 20000607
/2000Austria► SubscribePRODUCT NAME: BUPROPION HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-23680 20000616; FIRST REGISTRATION: NL 24160 19991201
2000 00018Denmark► SubscribePRODUCT NAME: BUPROPIONHYDROCHLORID; NAT. REG. NO/DATE: 31347 20000606; FIRST REG. NO/DATE: NL 24160 19991201
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Baxter
Merck
AstraZeneca
US Army
Citi
Colorcon
Boehringer Ingelheim
Teva
Argus Health
Johnson and Johnson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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